Empagliflozin meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in Phase III trial in adults with and without diabetes
Empagliflozin meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in Phase III trial in adults with and without diabetes
  • 뉴스와이어
  • 승인 2020.08.03 06:40
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Positive top-line results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, were announced today by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY). EMPEROR-Reduced met its primary endpoint, demonstrating superiority with empagliflozin (10 mg) compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure, when added to standard of care. Overall, the safety profile was similar to the known safety profile of empagliflozin.

“Heart failure is a common, but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide,” said Milton Packer, M.D., Chair of the Executive Committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas, Texas, US. “The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments.”

Heart failure is the leading cause of hospitalization in the US and Europe, and the number of patients across Asia is also increasing.[2] The risk of death in people with heart failure rises with each hospital admission.[3] Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart.[4] Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.[5]

“One in five people can expect to develop heart failure in their lifetime, so it is very encouraging to see these positive results from the EMPEROR-Reduced trial demonstrating that empagliflozin improves heart failure outcomes,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are excited to share the full results and are working tirelessly to explore how empagliflozin can improve the lives of people living with heart failure.”

Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the European Society of Cardiology (ESC) congress 2020 on 29 August, and regulatory submissions are planned in 2020. A second trial, EMPEROR-Preserved, is exploring the effect of empagliflozin on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction - an area with no approved treatment options.[6,7] EMPEROR‑Preserved results are expected in 2021.

The EMPEROR trials are part of the EMPOWER clinical program, one of the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.

“These results build upon the already established cardiovascular benefits of empagliflozin in adults living with type 2 diabetes and cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “Metabolic conditions that affect the heart and kidneys can lead to serious consequences, including hospitalizations and death. Through our EMPOWER clinical program, we are committed to advancing knowledge about these devastating clinical outcomes. We look forward to seeing how empagliflozin can help adults around the world living with these conditions.”

 


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